Absolute Bioavailability, Pharmacokinetics and Safety of ESR 1150 CL 1 mg Capsule Compared to 0.015 mg Solution i.v. as Single Administration in Healthy Male Subjects (Open-labelled, 2-way Cross-over Study)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Area under the plasma drug concentration-time curve from time zero to infinity
研究概览
简要总结
To investigate the bioavailability of ESR 1150 CL by the time course determination of plasma concentration (pharmacokinetics) of no-transformed ESR 1150 after single administration to healthy adult male volunteers. Secondary objective is to investigate the safety of ESR 1150 CL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •healthy male subjects
- •age: >= 20 and <= 35 years
- •weight: >= 50 to <= 80 kg and within +/- 20 % of standard weight
- •blood pressure: systolic 100 - 138 mmHg and diastolic of less than 84 mmHg
- •pulse rate: 45 to 80 beat/min
- •volunteer whose participation in the trial is judged valid by the investigator based on the results of preliminary check-up and pre-administration check-up
排除标准
- •history of diseases including cardiac, pulmonary, hepatic, renal or gastrointestinal disease
- •history of drug allergy
- •history of drug dependency, alcohol dependency, etc.
- •use of other trial drug within 6 months before study drug administration
- •use of any drugs within 7 days before study drug administration
研究组 & 干预措施
ESR 1150 CL ampoule
干预措施: ESR 1150 CL, solution, intravenous (Drug)
ESR 1150 CL capsule
干预措施: ESR 1150 CL, Capsule, oral (Drug)
结局指标
主要结局
Area under the plasma drug concentration-time curve from time zero to infinity
时间窗: up to 16 hours after drug administration
maximum drug plasma concentration (Cmax)
时间窗: up to 16 hours after drug administration
time to achieve maximum drug plasma concentration (tmax)
时间窗: up to 16 hours after drug administration
elimination half-life (t1/2)
时间窗: up to 16 hours after drug administration
mean residence time (MRT)
时间窗: up to 16 hours after drug administration
total clearance (CL)
时间窗: up to 16 hours after drug administration
次要结局
- number of adverse events(up to day 22)